SANATOS SEVERE COLD AND COUGH DAY TIME- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride granule, for solution 
Pharmadel LLC

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SanaTos Severe Cold and Cough Daytime

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/ fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCI 10 mgNasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing Acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOIs) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • for more than 7 days for pain and 3 days for fever, unless directed by a doctor

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if

  • taking the blood thinning drug warafin

Stop use and ask a doctor if

  • a persistent cough or symptoms do not improve within 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • new symptoms occur
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur

If pregnant or breast-feeding, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

AgeDose
adults & children 12 yrs. of age & overone packet every 4 hours
children under 12 yrs. of agedo not use

Other information

TAMPER EVIDENT: Do not use if packets are broken or torn.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue 1, FD&C red 40, flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions or Comments?

1-866=359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Distributed by/ Distribuido por:
PHARMADEL

Georgetown, DE 19947

Made in India

PRINCIPAL DISPLAY PANEL

SanaTos ® Severe COLD & COUGH

NDC 55758-010-01

NDC 55758-010-06

Box

SANATOS SEVERE COLD AND COUGH DAY TIME 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-010-066 in 1 CARTON; Type 0: Not a Combination Product02/20/2014
2NDC:55758-010-011 in 1 POUCH; Type 0: Not a Combination Product02/20/2014
3NDC:55758-010-1818 in 1 CARTON; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/20/2014
Labeler - Pharmadel LLC (030129680)

Revised: 11/2024
Document Id: 27369b75-8435-86f3-e063-6394a90a44ad
Set id: b995a0b2-898d-4a8f-b44f-097ae54e0ba5
Version: 6
Effective Time: 20241118
 
Pharmadel LLC